Evidence map›Paper›PMID 38843916›Full record

Trial reportThe European respiratory journal2024

A randomised phase II study of extended pleurectomy/decortication preceded or followed by chemotherapy in patients with early-stage pleural mesothelioma: EORTC 1205.

Jo Raskin, Veerle Surmont, Alexander P W M Maat, Maha Yahia, Sjaak A Burgers, Yassin Pretzenbacher, Frederic De Ryck, Robin Cornelissen, Houke M Klomp, Ana Oliveira and 5 more

Abstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The European respiratory journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Jo RaskinDepartment of Thoracic Oncology and Pulmonology, Antwerp University Hospital, Edegem, Belgium jo.raskin@uza.be.ORCID https://orcid.org/0000-0001-8029-4093
Veerle SurmontDepartment of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Alexander P W M MaatEuropean Network of Rare and Low Prevalent Diseases (ERN-Lung).
Maha YahiaDepartment of Medical Oncology, National Cancer Institute, Cairo, Egypt.
Sjaak A BurgersDepartment of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Yassin PretzenbacherEORTC Data Centre, Brussels, Belgium.
Frederic De RyckDepartment of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
Robin CornelissenEuropean Network of Rare and Low Prevalent Diseases (ERN-Lung).
Houke M KlompDepartment of Thoracic Surgery, Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID https://orcid.org/0000-0003-4999-8783
Ana OliveiraEORTC Data Centre, Brussels, Belgium.
Joachim AertsEuropean Network of Rare and Low Prevalent Diseases (ERN-Lung).
Paul BaasDepartment of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Sandrine MarreaudEORTC Data Centre, Brussels, Belgium.
Jan P Van MeerbeeckDepartment of Thoracic Oncology and Pulmonology, Antwerp University Hospital, Edegem, Belgium.
Paul E Y Van SchilCentre for Oncological Research (CORE), University of Antwerp, Edegem, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe role of surgery in pleural mesothelioma remains controversial. It may be appropriate in highly selected patients as part of a multimodality treatment including chemotherapy. Recent years have seen a shift from extrapleural pleuropneumonectomy toward extended pleurectomy/decortication. The most optimal sequence of surgery and chemotherapy remains unknown.

methodsEORTC-1205-LCG was a multicentric, noncomparative phase 2 trial, 1:1 randomising between immediate (arm A) and deferred surgery (arm B), followed or preceded by chemotherapy. Eligible patients (Eastern Cooperative Oncology Group 0-1) had treatment-naïve, borderline resectable T1-3 N0-1 M0 mesothelioma of any histology. Primary outcome was rate of success at 20 weeks, a composite end-point including 1) successfully completing both treatments within 20 weeks; 2) being alive with no signs of progressive disease; and 3) no residual grade 3-4 toxicity. Secondary end-points were toxicity, overall survival, progression-free survival and process indicators of surgical quality.

findings69 patients were included in this trial. 56 (81%) patients completed three cycles of chemotherapy and 58 (84%) patients underwent surgery. Of the 64 patients in the primary analysis, 21 out of 30 patients in arm A (70.0%; 80% CI 56.8-81.0%) and 17 out of 34 patients (50.0%; 80% CI 37.8-62.2%) in arm B reached the statistical end-point for rate of success. Median progression-free survival and overall survival were 10.8 (95% CI 8.5-17.2) months and 27.1 (95% CI 22.6-64.3) months in arm A, and 8.0 (95% CI 7.2-21.9) months and 33.8 (95% CI 23.8-44.6) months in arm B. Macroscopic complete resection was obtained in 82.8% of patients. 30- and 90-day mortality were both 1.7%. No new safety signals were found, but treatment-related morbidity was high.

interpretationEORTC 1205 did not succeed in selecting a preferred sequence of pre- or post-operative chemotherapy. Either procedure is feasible with a low mortality, albeit consistent morbidity. A shared informed decision between surgeon and patient remains essential.

Indexed as

MesotheliomaPleural NeoplasmsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleHumansMaleMesothelioma, MalignantMiddle AgedNeoplasm StagingPleuraPneumonectomyProgression-Free SurvivalTreatment Outcome

Identifiers

PMID38843916
PMCPMC11211697

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.